Texas
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001-33004
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76-0333165
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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2635 Technology Forest Blvd., The Woodlands, Texas
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77381
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (281) 272-9331
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N/A
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(Former name or former address, if changed since last report)
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Exhibit No. |
Description
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99.1 | Press release issued by Opexa Therapeutics, Inc. on May 12, 2016 regarding quarterly earnings. |
OPEXA THERAPEUTICS, INC. | |||
Dated: May 12, 2016
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By:
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/s/ Neil K. Warma | |
Neil K. Warma | |||
President, Chief Executive Officer and | |||
Acting Chief Financial Officer |
Exhibit No. |
Description
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99.1 | Press release issued by Opexa Therapeutics, Inc. on May 12, 2016 regarding quarterly earnings. |
●
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The Phase 2b clinical trial of Tcelna® (imilecleucel-T) in secondary progressive multiple sclerosis (SPMS) (Abili-T trial) continued to advance towards completion. Top line data is expected in early fourth quarter of 2016. The final dose was administered to the last patient in the last week of February 2016 and approximately 98% of all patient visits have now been completed. The Abili-T clinical trial is a randomized, double-blind, placebo-controlled study being conducted at approximately 35 leading clinical sites in the U.S. and Canada. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in SPMS.
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●
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In February 2016, a regularly scheduled meeting of the independent Data Safety Monitoring Board (DSMB) took place. The DSMB recommendation was to continue the Abili-T study as per protocol. The DSMB also stated that because dosing has been completed and no concerns over safety had been noted, no further DSMB meetings would be required for the Abili-T study.
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●
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In April 2016, Neil K. Warma, Opexa's President and Chief Executive Officer, was invited to present at Cellular Horizons: The Third International Conference on the Progress of Regenerative Medicine and its Cultural Impact, in Vatican City. Mr. Warma was among the world's leading cell therapy scientists, physicians, patients, ethicists and leaders of faith, government and philanthropists discussing the latest cellular therapy breakthroughs and the hope they provide for the future treatment of disease. Mr. Warma's presentation was entitled, "Can T-cells be Used to Treat Neuromyelitis Optica (NMO) and Other Autoimmune Disorders?"
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●
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Cash position: Cash and cash equivalents were $9,955,449 as of March 31, 2016, compared to $12,583,764 as of December 31, 2015.
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●
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R & D Expense: Research and development expenses were $1,829,062 for the quarter ended March 31, 2016, compared to $2,636,999 for the quarter ended March 31, 2015. The decrease in expenses is primarily due to a decrease in the costs in connection with the ongoing clinical trial of Tcelna in SPMS, a decrease in the procurement and use of supplies for product manufacturing and development, a decrease in employee and stock-based compensation expense as well as a reduction in the facility cost.
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●
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G & A Expense: General and administrative expenses were $987,248 for the quarter ended March 31, 2016, compared to $1,006,130 for the quarter ended March 31, 2015. The decrease in expenses is primarily due to the reduction in employee stock-based compensation expense and a decline in consulting services. This is offset by an increase in employee compensation including severance payments and severance accruals due to the March 2016 restructuring initiative.
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●
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Net loss: Net loss reported for the quarter ended March 31, 2016 was $2,160,394, or $.31 per share (basic and diluted), compared with a net loss of $3,350,880, or $.95 per share (basic and diluted), for the quarter ended March 31, 2015. The decreased net loss is primarily related to the decrease in research and development expenses, specifically site payments relating to the ongoing Abili-T clinical trial and related lab supplies. The decreased net loss is also due to the increase in revenue of $348,838 recognized in connection with the additional $3.0 million in funding from Merck Serono for Phase III planning which was received in March 2015. General and administrative expenses, specifically a reduction in the Black Sholes and consulting expenses, also reduced our net loss for the three months ended March 31, 2016.
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●
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Based on the current activities of the Company and projected burn, Opexa believes it has sufficient liquidity to support its current clinical activities for the Abili-T trial of Tcelna in SPMS, to continue planned preclinical development activities for OPX-212 in NMO, and for general operations to sustain the Company and support such activities through the first quarter of 2017. Opexa expects top-line data for the Abili-T trial to be available early in the fourth quarter of 2016, and thus believes it has sufficient resources to complete such trial.
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Three Months
Ended March 31,
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||||||||
2016
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2015
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|||||||
Revenue:
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||||||||
Option revenue
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$
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726,291
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$
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377,453
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||||
Expenses:
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||||||||
Research and development
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1,829,062
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2,636,999
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||||||
General and administrative
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987,248
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1,006,130
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||||||
Depreciation and amortization
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72,589
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96,982
|
||||||
Operating loss
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(2,162,608)
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(3,362,658
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)
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|||||
Interest income, net
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108
|
731
|
||||||
Other income, net
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2,106
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11,047
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||||||
Net loss
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$
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(2,160,394
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)
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$
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(3,350,880
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)
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||
Basic and diluted loss per share
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$
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(.31
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)
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$
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(.95
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)
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||
Weighted average shares outstanding - Basic and diluted
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6,982,909
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3,529,344
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Selected Balance Sheet Data:
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||||||||
March 31,
2016
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December 31,
2015
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|||||||
Cash and cash equivalents
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$ | 9,955,449 | $ | 12,583,764 | ||||
Other current assets
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932,409 | 995,067 | ||||||
Property and equipment, net
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765,763 | 837,867 | ||||||
Total assets
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11,653,621 | 14,416,698 | ||||||
Total current liabilities
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4,044,900 | 4,801,436 | ||||||
Total stockholders’ equity
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7,608,721 | 9,615,262 | ||||||
Total liabilities and stockholders’ equity
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$ | 11,653,621 | $ | 14,416,698 |